Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females (MGH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The purpose of this study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by antidepressant drugs. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject is female, age 18 to 80 years

Subject has been taking an SSRI, venlafaxine, or tri/heterocyclic antidepressant for the treatment of depression for at least 8 weeks; and is currently on a stable dose of the antidepressant for at least 4 weeks

Subject is currently euthymic (HAM-D < 10) and is without significant anxiety symptoms (HAM-A < 10)

Subject must have had no sexual dysfunction prior to taking antidepressant and there must be a clear temporal relationship between the sexual dysfunction and the antidepressant treatment

Subject must have been consistently experiencing at least one of the following criteria for at least 4 weeks, with distress or disability:

Inability to have an orgasm, according to patient opinion

Clinically significant orgasm delay with masturbation or intercourse

Inability to attain or maintain until completion of sexual activity an adequate lubrication swelling response of sexual excitement

Decreased libido according to patient opinion

Subject must be having or had been having some form of regular sexual activity (masturbation, oral sex, intercourse) at least twice monthly prior to the antidepressant treatment and are willing to continue efforts at sexual activity at least once weekly for the duration of the study

Subject must be in good general physical health

Subject must be able to understand and communicate in English

Subject must have given informed consent to participate in the study

Exclusion Criteria:

Primary or prior diagnosis of a sexual disorder (other than the side effect of the bipolar medication or symptom of the bipolar disorder)

Recent major relationship changes, disruption, or turmoil ongoing or anticipated which are unrelated to her sexual dysfunction

Hamilton Depression and/or Anxiety Scale score (either) > 10

Blood pressure outside the range of 90/50 - 170/100

Known hyperprolactinemia

Use of investigational drugs within previous 3 months or during study

Current use of other drugs for antidepressant induced sexual dysfunction or other therapies or medications to treat sexual dysfunction

Current use of nefazodone

Hormone replacement therapy, unless patient has been on stable dose of hormone therapy for at least 3 mo prior to the antidepressant treatment and had no sexual dysfunction while on the same hormone therapy regimen, and there is no change in the HRT during the study

Pregnancy, lactating, or planning to become pregnant during the study

Child bearing potential subjects unwilling and/or not prepared and/or who are judged unreliable to use an acceptable and verifiable form of contraception during the study

Any clinically significant abnormality on the screening physical examination

History of hormonal cancers

Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study, or that may increase the risk to subjects or others as a result of participating in this study

Dyspareunia secondary to an inflammatory or anatomical condition

Prior use of maca for at least two weeks

Infection of the urogenital tract that may make sexual activity painful or difficult

Receiving psychosexual or other therapy for sexual dysfunction and not willing to discontinue that treatment at screening

Subjects who do not understand and communicate in English

Subjects for whom sexual activity is inadvisable

Subjects whose sexual dysfunction is considered to be situational

Subjects not attempting some form of regular sexual activity at least twice monthly and at least once weekly during study visit intervals for duration of entire study

Changes in antidepressant agent and/or dose of medication within the last 4 weeks before baseline visit

Participants on medications with a narrow therapeutic window or low therapeutic index for which small variations may be harmful given the lack of systematic experience with drug-supplement interactions (i.e. - cyclosporine, digoxin, warfarin, and antiretrovirals)